Plain English Summary

Background and study aims Functional dyspepsia is a condition that causes an upset stomach or pain or discomfort in the upper belly, near the ribs. Probiotics are live bacteria and yeasts promoted as having various health benefits, which can taken as food supplements. The aim of this study is to assess the effects of a probiotic in patients with functional dyspepsia.

Who can participate? Patients aged between 18 and 80 with functional dyspepsia

What does the study involve? Participants are randomly allocated to take either a probiotic, a probiotic with a lipidic (fat) emulsion (Fabuless), or a placebo (dummy supplement). Blood samples are collected and functional dyspepsia symptoms are assessed in all three groups.

What are the possible benefits and risks of participating? Not provided at time of registration

Where is the study run from? Instituto Central do Hospital das Clínicas (ICHC) (Brazil)

When is the study starting and how long is it expected to run for? January 2012 to December 2012

Contact details

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Therapeutic efficacy of a probiotic compaond in dyspeptic patients: a randomised controlled trial

Acronym

Study hypothesis

Functional dyspesia is the most common functional disease of the upper gastrointestinal (GI) tract, its prevalence is around 20-40% in the eastern population of Brazil. Functional dyspepsia is a disease whose physiopathology is dependent of gastric motiliy as well as gut microbiota. Probiotics can interfere wiith both. The chronic use of such supplements can improve dyspepsia.

Ethics approval

Universiy of São Paulo Ethics Commitee, 31/08/2011

Study design

Prospective randomized double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Functional dyespesia

Intervention

150 patients with functional dyspepsia will be divided into three groups:1. Probiotic2. Probiotic + lipid3. Placebo

They will receive the products for 3 months, symptoms and biochemistry will be achieved before the study, in the end of the products supplementation and 3 months after stopping the products.